Tirzepatide (Spartina) in Obese Kidney Transplant Recipients
ConditionTirzepatide
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShahid Beheshti University of Medical Sciences
About this trial
Post-transplant obesity is a common complication after kidney transplantation, largely attributed to recovery from uremia, increased appetite, sedentary lifestyle, and long-term corticosteroid exposure. Obesity in kidney transplant recipients increases the risk of cardiovascular disease, post-transplant diabetes mellitus (PTDM), and may contribute to graft injury through hyperfiltration-related mechanisms, potentially leading to reduced graft survival. Current approaches for weight management in transplant recipients, including lifestyle modification, are often insufficient, while bariatric surgery carries considerable risks and concerns regarding altered absorption of immunosuppressive medications.
Tirzepatide (Iranian brand name: Spartina), the first dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, has demonstrated superior effects on weight reduction and glycemic control compared with earlier GLP-1 receptor agonists in the general population. However, its use in kidney transplant recipients requires careful evaluation due to potential gastrointestinal adverse effects, dehydration risk, and possible interaction with calcineurin inhibitor absorption caused by delayed gastric emptying.
This prospective single-arm pilot clinical trial aims to assess the preliminary safety and efficacy of tirzepatide in obese kidney transplant recipients with stable graft function. Outcomes include changes in anthropometric indices, percent weight change, gastrointestinal tolerability, immunosuppressive drug trough levels, and graft function over 24 weeks of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Kidney transplant recipient with ≥12 months since transplantation
BMI ≥ 27 kg/m²
Stable graft function in the last 3 months (serum creatinine variation < 20%)
Disqualifiers
History of pancreatitis
Severe gastroparesis
History of medullary thyroid carcinoma (MTC) or MEN2 syndrome
eGFR < 30 mL/min/1.73m²
Trial design
Design model
Single group
Treatments tested in this trial
Tirzepatide
Drug* Route: Subcutaneous injection (SC) * Frequency: Once weekly * Duration: 24 weeks * Dose escalation: * Weeks 1-4: 2.5 mg weekly * Weeks 5-8: 5 mg weekly (if tolerated) * Weeks 9-24: Continue 5 mg weekly or increase to 7.5 mg weekly based on tolerability and physician judgment
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Tirzepatide(Spartina)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change in Body Weight From Baseline at Week 24
Percent change in body weight compared to baseline
Time frame
Baseline to Week 242
Incidence of Gastrointestinal Adverse Events
Number of participants with gastrointestinal adverse events ( nausea, vomiting, diarrhea, constipation, abdominal pain) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame
Baseline to Week 24 (monthly assessment)3
Change in Serum Creatinine
Change from baseline in serum creatinine (mg/dl).
Time frame
Baseline to Week 24Secondary outcomes
1
Change in Body Mass Index (BMI)
changes in BMI
Time frame
Baseline to Week 242
Change in Waist Circumference
changes in centimeters
Time frame
Baseline to Week 243
Proportion of Participants Achieving Clinically Meaningful Weight Loss • Definition
≥5% and ≥10% weight loss from baseline
Time frame
week 244
change in tacrolimus trough Level
Change from baseline in tacrolimus trough level (ng/ml)
Time frame
Monthly monitoring through Week 24Sponsors and contacts
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Source ClinicalTrials.gov